NCT05747248

Brief Summary

Nowadays endotracheal intubation is considered a fundamental management procedure during emergency resuscitation. Unrecognized misplacement of the ETT during endotracheal intubation and ventilation, has a reported incidence of 2.9-16.7% and is a frequent cause of morbidity and mortality in emergency intubations. The aim of this study is to determine the diagnostic accuracy of the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

February 17, 2023

Last Update Submit

February 28, 2023

Conditions

Keywords

ETT

Outcome Measures

Primary Outcomes (1)

  • The verification of endotracheal tube position using the ultrasonography in the respiratory intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)

    The confirmation of endotracheal tube position using the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)

    one hour

Interventions

Tracheal, diaphragmatic and lung ultrasonography

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients intubated with a cuff ETT

You may qualify if:

  • Age \>18 years old with endotracheal intubation
  • Having normal airway anatomy

You may not qualify if:

  • Age below 18 years old
  • Neck deformities,
  • Presence in history of neck radiation,
  • Cervical spine immobility/instability
  • Unstable vital signs
  • Unwilling to participate or denial of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Islam Galal Sayed

Asyut, Egypt

Location

Related Publications (1)

  • Sethi AK, Salhotra R, Chandra M, Mohta M, Bhatt S, Kayina CA. Confirmation of placement of endotracheal tube - A comparative observational pilot study of three ultrasound methods. J Anaesthesiol Clin Pharmacol. 2019 Jul-Sep;35(3):353-358. doi: 10.4103/joacp.JOACP_317_18.

    PMID: 31543584BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 28, 2023

Study Start

December 1, 2021

Primary Completion

August 20, 2022

Study Completion

October 31, 2022

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations